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NCT06726148 · ClinicalTrials.gov registry record · Phase 1
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
A Phase 1 study of Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT06726148: Recruiting Phase 1 study of Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, sponsored by Novartis Pharmaceuticals.
NCT06726148 is a Phase 1 study of Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 280 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (367% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06726148, a Phase 1 study of Advanced HR+/HER2- Breast Cancer and Advanced CCNE1-amplified Solid Tumors, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
Primary Outcome
A DLT is defined as an adverse event or abnormal laboratory value of Common Terminology Criteria for Adverse Events (CTCAE) grade ≥ 3 assessed as unrelated to disease, disease progression, inter-current illness or concomitant medications that occurs within the first 28 days of treatment. Other clinically significant toxicities may be considered to be DLTs, even if not CTCAE grade 3 or higher.
Conditions Studied
Interventions
- DRUG ribociclib
- DRUG fulvestrant
- DRUG ECI830
Study Locations (20)
Other
- Novartis Investigative Site - Brno
- Novartis Investigative Site - Copenhagen
- Novartis Investigative Site - Odense C
- Novartis Investigative Site - Bordeaux
- Novartis Investigative Site - Saint-Herblain
- Novartis Investigative Site - Heidelberg
- Novartis Investigative Site - Ulm
Victoria
- Novartis Investigative Site - Clayton
- Novartis Investigative Site - Melbourne
California
- University of California LA - Los Angeles
Florida
- Florida Cancer Specialists - Fort Myers
Massachusetts
- Dana Farber Cancer Institute - Boston
Missouri
- WA Uni School Of Med - St Louis
New York
- Memorial Sloan Kettering - New York
Tennessee
- SCRI Oncology Partners - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2025-04-03 |
| Est. Completion | 2028-09-25 |
| Phase | Phase 1 |
What NCT06726148 shows while recruiting
NCT06726148 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (367% higher).
The record links to 2 conditions, with Advanced HR+/HER2- Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which ribociclib is the first listed.
NCT06726148 names 20 study sites across 13 states, led by Other, Victoria, California.
Frequently Asked Questions
What is clinical trial NCT06726148 about?
NCT06726148 is a clinical study titled "Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors". Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant i...
What is the current status of trial NCT06726148?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 280 participants. The study started on 2025-04-03. Estimated completion is 2028-09-25.
What conditions does trial NCT06726148 study?
This clinical trial studies the following conditions: Advanced HR+/HER2- Breast Cancer, Advanced CCNE1-amplified Solid Tumors.
What interventions are being tested in trial NCT06726148?
The interventions under investigation include: ribociclib (DRUG), fulvestrant (DRUG), ECI830 (DRUG).
Who is sponsoring clinical trial NCT06726148?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06726148 being conducted?
This trial has 20 study locations across California, Florida, Massachusetts, Missouri, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Advanced HR+/HER2- Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06726148's enrollment target sits among peer trials
280 141st of 2000 higher than 1,855 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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